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Guide on Drug Batch Uniformity and Integrity

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FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch unifo...

Chimerix NDA for Glioma Drug

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Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diff...

FDA Approves Novo Hemophilia Prophylaxis Drug

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FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.

New Sleep Apnea Indication for Lillys Zepbound

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FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.

Astellas Recalls Lots of Prograf and Astagraf

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FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.

QS, MDR Violations at Rontis Hellas in Greece

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FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon cathet...

FDA Approves BMS Opdivo Qvantig Injection

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FDA approves Bristol Myers Squibbs Opdivo Qvantig subcutaneous injection for several cancer indications.

FDA Approves Checkpoints Unloxcyt

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FDA approves Checkpoint Therapeutics Unloxcyt to treat some squamous cell cancer patients.

Axsome Plans Alzheimers NDA on Mixed Data

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Axsome Therapeutics plans an NDA submission for AXS-05 (dextromethorphan-bupropion) in the second half of next year for treating A...

Exclude Liraglutide from Compounding: Novo Nordisk

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Novo Nordisk petitions FDA to exclude its liraglutide from the agencys list of bulk drug substances that may be used by drug compo...